Sevotek 1000 mg/g Inhalation Vapour, Liquid for Dogs and Cats

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

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Active ingredient:

Sevoflurane

Available from:

Laboratorios Karizoo S.A

ATC code:

QN01AB08

INN (International Name):

Sevoflurane

Pharmaceutical form:

Inhalation vapour, liquid

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Dogs

Therapeutic area:

Neurological Agent general anaesthetic

Authorization status:

Authorized

Authorization date:

2018-02-19

Summary of Product characteristics

                                Unlimited Renewal: August 2022
AN: 01127/2022
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Sevotek 1000 mg/g inhalation vapour, liquid for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains:
ACTIVE SUBSTANCE:
Sevoflurane
1000 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation vapour, liquid.
Clear, colourless liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the induction and maintenance of anaesthesia.
4.3
CONTRAINDICATIONS
Do
not
use
in
animals
with
known
hypersensitivity
to
sevoflurane
or
other
halogenated anaesthetic agents.
Do not use in animals with a known or suspected genetic susceptibility
to malignant
hyperthermia.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Halogenated
volatile
anaesthetics
can
react
with
dry
carbon
dioxide
(CO2)
absorbents to produce carbon monoxide (CO) that may result in elevated
levels of
carboxyhaemoglobin in some dogs. In order to minimise this reaction in
rebreathing
anaesthetic circuits, the veterinary medicinal product should not be
passed through
soda lime or barium hydroxide that has been allowed to dry out.
Unlimited Renewal: August 2022
AN: 01127/2022
Page 2 of 9
The
exothermic
reaction
that
occurs
between
inhalation
agents
(including
sevoflurane) and CO2 absorbents is increased when the CO2 absorbent
becomes
desiccated, such as after an extended period of dry gas flow through
the CO2
absorbent canisters. Rare cases of excessive heat production, smoke
and/or fire in
the anaesthetic machine have been reported during the use of a
desiccated CO2
absorbent
and
sevoflurane.
An
unusual
decrease
in
the
expected
depth
of
anaesthesia compared to the vaporiser setting may indicate excessive
heating of the
CO2 absorbent canister.
If it is suspected that the CO2 absorbent may be desiccated, it must
be replaced. The
colour indicator
                                
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